The Role of Metformin and Colesevelam in Human GLP-1 Secretion

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Colesevelam; Drug: Metformin; Other: Placebo

• Registration Number: NCT02050074
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Normal hemoglobin
• BMI > 23kg/m2
• HbA1c <9 %
• Informed concent

Exclusion Criteria

• Liver disease ( aspartate aminotransferase/alanine aminotransferase >2 × reference value)
• Chronic intestinal disease
• History of liver and / or gallbladder disease
• Nephropathy (se-creatinine >110 µM and / or albuminuria)
• Insulin or GLP-1-based antidiabetic treatment
• History of cholecystectomy or surgical resection of bowel segment
• BMI <23kg/m2 or BMI >35 kg/m2
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Colesevelam + exendin (9-39)	Colesevelam	-
Metformin + exendin (9-39)	Metformin	-
Placebo + + exendin (9-39)	Placebo	-
Colesevelam	Colesevelam	-
Metformin	Metformin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in the gut hormone glucagon-like peptide 1 (GLP-1)	0-240 min

Trial Locations

Locations (1)

Diabetes Research Division, Department of Medicine, Gentofte Hospital; 🇩🇰 Hellerup, Copenhagen, Denmark